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Process Analytical Technologies (PAT) - Articles and news items

IFPAC®-2017 31st International Forum & Exhibition

Supplier news / 31 October 2016 / IFPAC

Emerging technologies to modernize pharmaceutical/biopharmaceutical development and manufacturing…

Whitepaper: Downstream biopharmaceutical operations

Application note: Downstream biopharmaceutical operations

Whitepapers, Z Homepage promo / 1 September 2016 / Kaiser Optical Systems, Inc

This Kaiser application note focuses on real-time, in situ process understanding using a Raman-based PAT approach. Raman spectroscopy is uniquely useful for biotechnology ‘Quality by Design’ (QbD) applications because it enables fast, non-destructive monitoring and control…

NIR-based on-line monitoring of lyophilisation processes

PAT Series: Recent achievements in NIR-based on-line monitoring of lyophilisation processes

Issue 3 2016 / 30 June 2016 / Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH

Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to special requirements with respect to optimal process control and reproducibility. Both these parameters are important factors affecting the product quality. Recent studies confirm the ability of NIR spectroscopy (NIRS) to provide insights into both drying phases of lyophilisation, that is, sublimation of ice and removal of adsorbed water…

Exploring the advantages of PAT for pharmaceutical cleaning in Ireland

Exploring the advantages of PAT for pharmaceutical cleaning in Ireland

Issue 2 2016, PAT & QbD / 4 May 2016 / Adeyinka Aina, University of Nottingham / Manuel Kuhs, Bernal Powder Engineering Research Group / Shaza Darwish, University of Limerick / Chris Edlin, Pharmaceutical Technology Manufacturing Centre

Process analytical technology (PAT) and its applications have been used in various industrial processes for a long time. It originates from the last century where its first application was in Germany after World War II within the chemical and petrochemical industry. Following this, it was implemented and refined in different industries worldwide – for example in refineries and petrochemical plants – until it became an integral part of process control. However, it is considered a young technology in pharmaceutical manufacturing where the processes have always been restricted to conventional approaches. This forces many limitations on product quality monitoring since the control relies mainly on collected samples being tested off-line in a laboratory…

Future proofing - Part 2. PAT – Real Time Release Testing of Tablets

Future proofing – Part 2. PAT – Real time release testing of tablets

Supplier news / 4 April 2016 / Charles Ischi AG | Kraemer Elektronik

What requirements need to be met by a tablet testing system to guarantee a successful product release?

The application of skip testing to drug substance manufacture

The application of skip testing to drug substance manufacture

Issue 1 2016, PAT & QbD / 29 February 2016 / Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline

Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that there is a low risk of any batches failing specification. In this article, a process is described (supported by an example) that could be followed to justify the use of skip testing. The process involves identifying attributes that are candidates for skip testing, performing a statistical evaluation to confirm there is a low risk of batch failure if skip testing is instigated and making ongoing assessments to confirm the process remains highly capable and the attribute(s) is predicted to be well within specification…

Application Note: MicroNIR PAT for blend monitoring

Application Note: MicroNIR PAT for blend monitoring

Whitepapers / 18 January 2016 / VIAVI

This paper discusses how the MicroNIR PAT spectrometer was used to monitor the blend uniformity of a number of designed blends of commercially available coffee, sugar and creamer and to jointly assess the sensory preference of the blends in a way that is typical of the process used by a pharmaceutical company to better understand the powder blending operation in tablet manufacturing…

Application note: In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes

Application note: In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes

Whitepapers / 15 January 2016 / Innopharma Labs

Determining CPP’s in DoE using Eyecon particle characteriser and Multieye Multipoint NIR…

PAT In-depth focus 2015

PAT: In-depth Focus 2015

Issue 6 2015, PAT & QbD, Supplements / 6 January 2016 / Caroline Richards

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable…

Fit-for-purpose miniature NIR spectroscopy for solid dosage manufacturing

Webinars / 26 October 2015 /

This webinar discusses how miniaturised spectrometers facilitate testing of different control schemes with the goal of enabling real-time feedback control of continuous manufacturing processes…

Continuous manufacturing in the pharma industry – an unstoppable trend?

Continuous flow processing in the pharma industry – an unstoppable trend?

Issue 5 2015, PAT & QbD / 22 October 2015 / Bernhard Gutmann and Christian Oliver Kappe, University of Graz

Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry emerged only comparatively recently and the vast majority of production is still undertaken in batch reactors. Herein, we highlight some of the advantages that continuous flow processing offers for the synthesis of pharmaceuticals and fine chemicals…

PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

Issue 4 2015, PAT & QbD / 3 September 2015 / Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen

Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability. However, whilst model-predictive monitoring is advantageous, it is also desirable to apply model predictions for closed loop control of biologics manufacturing using various process analytical technology (PAT) tools. We summarise some of our experiences with predictive monitoring, closed loop control usingin situRaman spectroscopy and state-space methods for model predictive control of cell culture bioreactors…

 

Webinar: Use of MicroNIR to optimise fluid bed drying and to reduce waste at tablet compressionWATCH NOW
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